The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference.

The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.

The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.

A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference

Further study details as provided by UltraShape:

Primary Outcome Measures:

The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods. [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective of this study subject satisfaction measured with a self-assessment questionnaire [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

Device: Treatment with Contour I-Y system

The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

Device: Treatment with Contour I-Y system

The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

Other Name: UltraShape® Contour I - Y System

Device: Treatment with Contour I-Y system

The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01609699